#54: Art of Writing a Clinical Overview

Jun 23 2013 9:00AM - Jun 23 2013 5:00PM | Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

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Learning Objectives

At the conclusion of this tutorial, participants should be able to:

Communicate the role of a Clinical Overview (Module 2.5) in a CTD
Describe the structure and format of a Clinical Overview in accordance with ICH guidelines
Develop strategies regarding the placement and presentation of information in different sections of the Clinical Overview
Explain how to effectively cross-reference to other components of the CTD
Develop a submission-ready Clinical Overview that successfully communicates all available information concerning the benefits and risks of an investigational product
Recognize how to modify the Clinical Overview for different submission types

Instructor(s)

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Patricia A. Matone, PhD

President
Scientific Information Services LLC, United States

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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